Orthotic devices and appliances commonly referred to as “orthotics,” are known in the prior art and have been utilized for many years by orthotists (a maker and fitter of orthotics), physical therapists, and occupational therapists to assist in the rehabilitation of a patient's joints and associated limbs or adjacent skeletal parts of the patient's body related to a condition known as osteoarthritis. Such early devices can be seen in U.S. Pat. No. 3,581,741 to Rosman, which discloses a knee brace comprising an upper rigid body portion and a lower rigid body portion pivotably coupled together on the lateral side in a manner so that they may pivot relative to each other about an axis generally perpendicular to the zone of overlap and may slide relative to each other in all radial directions generally parallel to the zone of overlap. In this application the words osteoarthritis knee orthosis is interchangeable with the term osteoarthritis knee brace.
Webster's New College Dictionary defines “orthotics” as a branch of mechanical medical science that deals with the support and bracing of weak or ineffective joints or muscles. The word “ortho” actually comes from Greek and means “to straighten.” Orthotics are used to support and straighten the effected joint and assist to correct normal human function as closely as possible. Orthotics used as limb braces have typically been designed to support and protect the joint that is associated with osteoarthritis, for alleviating pain associated with joint movement at the particular location being treated.
Primary osteoarthritis is typically related to the simple fact of aging and most often affects weight bearing joints, such as the knee. With aging, the water content of the cartilage between two bones in a joint tends to increase, whereby the protein makeup of the cartilage degenerates, which then causes it to become soft, frayed and thinned with eburnation of the subchondral bone. Repetitive use of a joint, such as the knee, over the years, which by the way is simply unavoidable and in fact is wholly necessary for normal human function, irritates and inflames the cartilage, thereby causing joint pain and swelling. Eventually, cartilage begins to degenerate by flaking or by forming tiny crevasses there within. In advanced cases, there is a total loss of the cartilage cushion between the femur and tibia bones at the knee joint, leading to diminished joint space on one or more affected sides of the knee resulting in pain and limitation of joint mobility. Inflammation of the cartilage can also stimulate new bone outgrowths (also known as “bone spurs”) to form around the joints causing increased pain and further joint inflammation thereby exacerbating the condition to a point where many people can barely walk, or if do so, is done with an extreme amount of pain.
Osteoarthritis is often described as “wear and tear” arthritis, as it is highly correlated to the age of a person. Osteoarthritis is one of the most frequent causes of physical disability among adults. More than 20 million people in the United States have the disease. By 2030, it is estimated that 20 percent of all Americans, approximately 70 million people, will have passed their 65th birthday and will be at risk for osteoarthritis. Other names for this disease are known as degenerative arthritis, degenerative joint disease, osteoarthrosis and arthrosis 2.
When referring to osteoarthrosis, it is generally accepted that it is a condition of degeneration of the effected joint. Osteoarthritis implies the same meaning, but the “itis” adds the meaning that the joint is inflamed. However, the two terms are often used interchangeably and can, should and will, for the purposes of the novel invention described hereinafter, be so interchangeably used.
Joint replacement surgery of the knee is the surgical treatment for osteoarthrosis or osteoarthritis. Most practitioners will recommend that it is best to delay knee joint replacement surgery as long as possible, as a total knee replacement may then need to be replaced in another ten to twenty years thereafter. Further, joint replacement surgery is a major surgical procedure, which requires considerable rehabilitation therapy to restore full function thereafter and full anesthesia during the surgical procedure. Joint replacement surgery should be a choice of last resort.
Surgical correction is very effective in alleviating the pain associated with knee OA and returning the patient's gait to a more normal walking pattern. However, as noted above, the surgery is expected to last only about 10 to 20 years because of the typical life of the artificial components used to correct the knee joint. As such, younger patients are often not considered good candidates for this surgery. Other OA patients simply cannot afford total knee replacement surgery and may be poor candidates for other health reasons. These patients badly need new technology in OA bracing that provides rehabilitation of the OA knee and a delay to OA progression.
Exercise, weight loss, if needed, and the use of anti-inflammatory medications and analgesics are often first prescribed to assist the patient in managing the pain associated with osteoarthritis. In more advanced cases though, steroids may be employed. Regardless of the care chosen or employed, minimizing the progression of the damage to the cartilage of the knee joint and preventing the formation of bone spurs from “bone-on-bone” contact during knee joint flexion should be an important part of any and all patient care.
The actual pain of osteoarthritis or osteoarthrosis of the knee comes from a wearing away of the soft cartilage that pads the junction of the femur (upper leg bone of the knee) and the tibia (lower leg bone of the knee). With irritation of the joint, bone spurs can form causing bits of bone and cartilage to break off which float inside the joint space further irritating the knee and causing addition discomfort and paid.
The most common form of osteoarthritis or osteoarthrosis is unicompartmental, meaning that only one of the three compartments of the knee joint are significantly affected by the loss of the cartilage padding. When speaking of a “compartment of the knee,” it is meant to be the area that is a separate section or chamber between the end portions of closely juxtaposed bones. In a healthy knee, these “compartments” contain the cartilage and synovial fluid, a thick and stringy fluid that acts as a lubricant in the joint that helps to reduce friction therein.
The “medial compartment” of the knee is on the inside of the center line of the body, whereas, the “lateral compartment” of the knee is on the outside plane of the body. The “patellar compartment” is on the center top of the knee behind the patella or knee cap.
The majority of cases of osteoarthritis of the knee experience medial compartment degeneration wherein the cartilage or cushioning of the knee joint has significantly deteriorated. The knee then becomes imbalanced, with the knee bowing outwardly. This is often called a “bowlegged” condition or a “varus deformity” of the knee joint, wherein significant force is exerted on the medial compartment of the knee, which then causes significant pain when the patient walks, bends the knee, or stands up. As a result, the patient typically adopts an abnormal gait, which is most often recognized by an exaggerated swinging of the hips. This abnormal gait can progress the osteoarthritis and lead to a more serious condition. Recent studies on the effects of abnormal gait and how it leads to OA progression have recently been conducted and have shown this to be an aggravating factor of OA disease.
Without proper treatment, which should include a corrective and therapeutic force system incorporated into an OA brace to correct an abnormal gait, OA progression in a patient can lead to a pathological OA condition, which will most likely force the patient into the necessary, but highly undesirable and expensive, surgical knee joint replacement. To date, no OA knee braces in the prior art incorporate such a corrective and therapeutic force system; but such a system is clearly needed. Further, “regular” abnormal gait, let alone pathological OA gait, causes an abnormal swinging of the hips and can result in more severe problems for the patient by placing abnormal stress and force on the hip joints, which if left unchecked or untreated will most often lead to a secondary condition for the patient of osteoarthritis of the hip. The patient is essentially doing more damage to the body as a whole by swinging the hips abnormally by rotating or “torquing” the knee joint, or what is also known as a “reverse screw home mechanism.”
Besides the physical pain associated with medial compartmental degeneration, OA of the knee can cause the patient to feel awkward, inadequate and embarrassed from this abnormal gait, which can then lead to an even more sedentary and reclusive lifestyle, which can further lead to aggravated psychological conditions, such as depression.
Returning back to the specific causes of an osteoarthritis knee condition, as the cartilage or padding of the knee joint on an effected lateral compartment cartilage is worn away the knee will again deform abnormally, but instead this time it will bend inwards at the knee joint, thereby giving the patient a knock-kneed appearance or a “valgus deformity” of the knee joint.
Osteoarthritis (OA) knee braces are known in the prior art and are primarily designed to do two things. First, correct the abnormal bending of the knee joint inwards or outwards (i.e., varus or valgus correction). Secondly, most OA knee orthotics or braces are designed to prevent the “bone-on-bone” contact of the femur and tibia bones in the medial and/or lateral compartment of the knee joint as the patient bares weight during ambulation. This action of lifting the femur, pulling down the tibia or keeping the femur and tibia bones from coming in contact during the straightening of the knee during heel strike of the foot is often called “unloading” of the knee joint, which is known to be only a temporary relief from pain by those stricken with such disease. By unloading the knee joint, the constant irritation of the degenerated cartilage in the effected compartment of the knee (medial or lateral) can lead to a reduction in pain and a further reduction in injury to the knee joint.
Prior art osteoarthritis knee braces also provide improved alignment of the upper and lower aspects of the knee joint by preventing the bending inwards or outwards of the knee joint during gait. These two features, unloading and alignment, are provided by almost all osteoarthritis knee orthotics available in today's market and those products that are known in the prior art. When these prior art braces are removed however, little or no rehabilitation of the knee occurs and a return of the pain without brace use is apparent. This reinforces the fact that prior art “unloading” braces lack any significant rehabilitative components, which could actually strengthen the leg and improve the knee joint balance to delay the progression of OA and to improve the patient's condition when the brace is not being worn.
Further, none of the OA braces in the prior art work to correct walking gait kinetics to an actual or more “normal gait.” In fact, while the prior art devices may assist in straightening the leg somewhat, the patient will still be seen striking the foot along an outside edge on a varus deformity (bowlegged) condition and on an inside edge on a valgus deformity (knock-kneed) condition. This is because none of the prior art devices use a corrective and therapeutic force system in coincidence with the OA brace to return the patient to a true, more normal gait wherein actual heel-to-toe striking along the ground surface is realized along with a lengthening of the leg step. Further, none of the prior art devices use a corrective and therapeutic force system in combination with a swing-assist system that forces activation of atrophied muscles, such as the quadriceps, which actually rehabilitates the effected area and encourages these atrophied muscles, through recruitment, to begin to work again, thereby assisting the patient to return to the closest, more normal gait as possible based upon the severity and progression of their specific disease condition. None of the prior art OA braces actually rehabilitate and strengthen the leg musculature, with any significance, such that after several months of routine brace use, there is a significant less amount pain when walking or standing or when not using the brace as compared to the pain experienced prior to brace use.
Further, a majority of knee orthotics available to treat osteoarthritis of the knee utilize a single upright attached to an upper thigh cuff and lower shin cuff. The upright is located on the side of the collapsed compartment of the knee (i.e., medial side for medial compartment osteoarthritis or lateral side for lateral compartment osteoarthritis). The attached cuffs “unload” the biomechanical force on the effected compartment of the knee by increasing the joint space on the effected side as the knee goes from flexion to extension.
Many known osteoarthritis knee braces use an angled strap from the upper part of the brace that then goes across the opposite side of the knee joint from the single upright to the lower part of the brace to improve the alignment of the knee during ambulation to and better balance the forces on the knee during gait kinetics more evenly. Such a brace can be seen with the devices marketed by the company ÖSSUR. The strap provides a three point leverage system that attempts to pull the knee joint into proper alignment during gait. A combination of the single sided upright with cuff attachments and the valgus producing strap have shown to provide improved performance in severe genu varum osteoarthritis. However, it is difficult to set the desired degrees of flexion and extension in such devices and therefore these devices are known to fall short of providing a close-to-complete alleviation of the pain and discomfort from osteoarthritis and a return to normal walking gait, let alone providing any a corrective and therapeutic force system to rehabilitate the effected knee joint and surrounding muscles. Further, patient discomfort and brace slippage is a real and common problem with braces designed as such.
Other known brace designs employ a double upright strut, which merely immobilizes the knee by unloading the degenerative knee compartment and thereafter doing nothing more. In some prior art devices, non-slippage and comfort pads are employed along inner lateral surfaces of said upright struts. However, none of these prior art devices disclose, teach or suggest the use of cushion pads, let alone inflatable or pneumatic bladders to apply an additional corrective or therapeutic force to rehabilitate the knee joint and surrounding muscles through forced work and recruitment. Still further, none disclose a system that works in coincidence with the corrective or therapeutic forces to equally distribute said forces.
There is also a need to provide a swing-assist activity to patients with either medial or lateral compartmental osteoarthritis. The ÖSSUR devices provide no such function, nor do any other known OA braces in the prior art.
Still further, although many of the existing knee braces containing locking hinge assemblies serve their intended purpose, difficulty in ease of setting the desired degrees of flexion and extension continues to be a problem, which clearly needs improvement.
What is therefore needed is a complete OA knee brace that can unload the knee, stabilize the effected compartment, provide a swing-assist function for extension of the knee, provide a corrective and therapeutic force that can return the patient to a more true normal gait (heel-to-toe strike while walking) and prevent abnormal rotation of the knee joint, all the all the while recruiting atrophied muscles to work again and to rehabilitate themselves so that the patient can once again return to the closest possible “normal” condition based upon the specific progression of their respective disease condition. The goal for any advancement in the art should be an improvement from “abnormal OA gait” to a more biomechanically correct normal gait kinetic, which reduces the knee adduction movement believed to be a casual but significant factor in OA knee compartment degeneration. A truly rehabilitative OA knee brace would strengthen the leg musculature and improve knee joint space balance over time using dynamic adjustable components such that a reduction in pain over time, with and without brace use, would be both evident and realized. Such a described and needed brace currently does not exist in anywhere in the prior art. Simply put, an improved OA knee brace should be used with patients who can begin “brace therapy” prior to OA becoming too severe to effectively improve the condition and thereby avoid pathological OA.